Analyte monitoring

Abstract

Devices and methods for determining the concentration of an analyte are provided. Embodiments of the subject devices include analyte monitoring systems that include an analyte sensor capable of providing clinically accurate analyte data without a substantial time delay after operably positioning the sensor in a patient. Embodiments of the subject methods include operably positioning an analyte sensor in a patient and obtaining clinically accurate analyte data without a substantial time delay after the positioning. Also provided are systems and kits for use in analyte monitoring.

Description

BACKGROUND OF THE INVENTION [0001] The monitoring of the level of glucose or other analytes, such as lactate or oxygen, in certain individuals is vitally important to their health. High or low levels of glucose or other analytes may have detrimental effects. For example, the monitoring of glucose is particularly important to individuals with diabetes, as they must determine when insulin is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their bodies. [0002] A conventional technique used by many diabetics for personally monitoring their blood glucose level includes the periodic drawing of blood, the application of that blood to a test strip, and the determination of the blood glucose level using calorimetric, electrochemical, or photometric detection. This technique does not permit continuous or automatic monitoring of glucose levels in the body, but typically must be performed manually on a periodic basis. Unfortu...

AI Technical Summary

Benefits of technology

[0006] Generally, the present invention relates to methods and devices for monitoring of the level of an analyte using an in vivo or in vitro analyte sensor, e.g., continuous and / or automatic in vivo monitoring using an analyte sensor. Embodiments of the subject invention include sensors that do not exhibit, or at least have a minimal period of time in which, spurious, low reading are observed. The subject invention may be employed to minimize or eliminate spurious low analyte readings obtained at any time during sensor use, including a period of time immediately after sensor activation (e.g., positioning of an analyte sensor in or on a patient) and / or anytime thereafter. Embodiments include sensors in which at least a portion of the sensor is adapted to be positioned beneath the skin of a user and which are adapted for providing clinically accurate analyte data substantially immediately after the sensor has been operably positioned in a patient (e.g., in the subcutaneous tissue, etc.) and / or without substantial interruption due to spurious analyte readings.

[0012] Embodiments of the subject methods include analyte determination methods having a substantially reduced period of time when a first (or only) calibration is required (excluding factory-set calibration), after positioning the sensor in a patient, and / or the number of calibrations is reduced, e.g., to three or less calibrations, e.g., two or less calibrations, e.g., one calibration or no calibrations.

Problems solved by technology

High or low levels of glucose or other analytes may have detrimental effects.

This technique does not permit continuous or automatic monitoring of glucose levels in the body, but typically must be performed manually on a periodic basis.

Unfortunately, the consistency with which the level of glucose is checked varies widely among individuals.

Many diabetics find the periodic testing inconvenient and they sometimes forget to test their glucose level or do not have time for a proper test.

These situations may result in hyperglycemic or hypoglycemic episodes.

Regardless of the type of analyte monitoring device employed, it has been observed that transient, low readings may occur for a period of time.

These spurious low readings may occur during the first hours of use, or anytime thereafter.

For example, in the context of an operably positioned continuous monitoring analyte sensor under the skin of a user, such spurious low readings may occur for a period of time following sensor positioning and / or during the first night post-positioning.

However, these transient, low readings impose constraints upon analyte monitoring during the period in which the spurious low readings are observed.

Attempts to address this problem vary and include delaying reporting readings to the user until after this period of low readings passes after positioning of the sensor, or frequent calibration of the sensor—both of which are inconvenient and neither of which is desirable.

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